INDICATIONS

Accutane is given to patients for treating severe acne that do not respond to other medicines. Accutane is a retinoid. It works by reducing skin oil production, changing the characteristics of the skin oil, and preventing abnormal hardening of the skin.

INSTRUCTIONS

Use Accutane as directed by your doctor.

Take Accutane by mouth with food.

Swallow the capsule with a full glass of water or other liquid. Do not break, crush, chew, or suck on the capsule before swallowing. This will help prevent the medication inside the capsule from irritating your throat.

For best results, take Accutane regularly. Taking Accutane at the same time each day will help you remember to take it.

If you miss a dose of Accutane, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Accutane.

STORAGE

Store Accutane at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Accutane out of the reach of children and away from pets.

Do NOT use Accutane if:

you are allergic to any ingredient in Accutane

you are pregnant, planning to become pregnant, or become pregnant while taking Accutane

Some medicines may interact with Accutane. Tell your health care provider if you are taking any other medicines, especially any of the following:

Tetracyclines because of the risk of increasing pressure in the brain

St. John’s wort because of risk of failure of hormonal contraceptives (eg, birth control pills)

Vitamin A-type medicines (eg, etretinate, vitamin A) because they may increase the risk of Accutane’s side effects

Corticosteroids (eg, prednisone) or phenytoin because the risk of their side effects may be increased by Accutane

Progestin-only birth control (eg, “mini-pill”) because its effectiveness may be decreased by Accutane.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Accutane may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

Accutane may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Accutane with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

A sudden decrease in night vision may occur while you are taking Accutane. Use caution when driving at night and avoid driving at night if you experience decreased night vision.

If you wear contact lenses, you may have difficulty wearing them during and after therapy.

Do not give blood while taking Accutane and for 1 month after stopping taking Accutane.

Do not drink alcohol while taking Accutane.

Worsening of acne may occur during the first part of therapy. This does not suggest failure or a need to stop the medicine.

To prevent cracking of lips, use a lip moisturizer or balm.

Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are taking Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures.

Accutane may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Accutane. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Some patients, while taking Accutane or soon after stopping it, have become depressed or developed serious mental problems. Stop using Accutane and tell your health care provider right away if you have any of these symptoms: feeling sad or having crying spells; feeling anxious; becoming more irritable, angry, or aggressive than usual; losing pleasure or interest in social or sports activities; sleeping too much or too little; changes in weight or appetite; feeling like you have no energy; having trouble concentrating; having thoughts about taking your own life or hurting yourself (suicidal thoughts).

Sexually active women of childbearing age must use 2 effective forms of birth control at least 1 month before starting therapy, during therapy, and for 1 month after stopping the medicine. Your health care provider should conduct pregnancy tests on a monthly basis while you are taking Accutane.

Certain birth control pills (progestin-only pills, “mini pills”) that do not contain estrogen may not be as effective while you are taking Accutane.

You should not take the herbal supplement St. John’s wort because it makes birth control pills less effective.

Lab tests, including pregnancy tests, cholesterol and lipid levels, liver function, blood sugar levels, and white blood cell counts, may be performed while you use Accutane. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Accutane should not be used in children younger than 12 years old; safety and effectiveness in these children have not been confirmed.

Pregnancy and breast-feeding: Do not become pregnant. Accutane can cause serious birth defects, miscarriage, early birth, or death of the fetus. If you have sex at any time without using 2 forms of effective birth control, become pregnant, think you may be pregnant, or miss your menstrual period, stop using Accutane and call your health care provider. Do not breast-feed while taking Accutane and for 1 month after stopping Accutane. Accutane may pass through your milk and harm the baby.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling under the skin, swelling of the lips, and loss of balance or coordination.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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